Impact of Cilostazol Versus Cilostazol and Selenium Combination on the Healing of Diabetic Foot Ulcer Patients

Impact of Cilostazol Versus Cilostazol and Selenium Combination on the Healing of Diabetic Foot Ulcer Patients: a Randomized Controlled Trial

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06117436

Enrollment

206

Registered

2023-11-07

Start date

2023-10-19

Completion date

2025-01-30

Last updated

2025-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wound Heal

Brief summary

The growing incidence of DM can lead to the increased prevalence of diabetic foot complications, which have become a serious medical, social, and economic concern of global importance. this study aims to find a novel intervention that improve wound healing in diabetic foot ulcer to improve patients' quality of life, reduce amputation rate, and reduce the mortality rate among diabetic foot ulcer patients

Interventions

DRUGCilostazol

Cilostazol 100 MG oral tablet once daily antiplatelet, Selenium 200mcg tablet once daily, anti oxidant

DRUGSelenium

Selenium 200 mcg oral tablet once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Eligible patients will be adult diabetic patients aged 18 years and older with non-ischemic diabetic foot ulcers Wagner's grade 2, 3, and 4.

Exclusion criteria

1. Wagner's grade 5 patients (because of the indications for amputation). 2. Patients with poor glycemic control at the time of inclusion (HbA1c\>12%). 3. Patients who need either direct graft or indirect revascularization procedure during the study. 4. Patients with Cilostazol or Selenium allergy. 5. Patients with Cilostazol contraindications (Heart Failure, bleeding disorder). 6. Patients with a history of comorbidities that interfere with wound healing (cancers, congestive heart failure, end-stage renal disease, and liver failure). 7. Presence of clinical signs of active infection unresponsive to oral antibiotics (oedema, erythema, discharge, regional lymph node enlargement, pain, or fever). 8. Patients who take medications that interfere with wound healing (glucocorticoids, immunosuppressive and cytotoxic drugs) at the time of inclusion. 9. Non-diabetic patients with foot wounds due to vascular or dermatological reasons.

Design outcomes

Primary

Measure	Time frame	Description
Wound Healing size	3 months	ulcer length, width, and depth in Cm

Secondary

Measure	Time frame	Description
Effect on Matrix Metalloproteinase-9 (MMP-9) level	3 months	will be used by ELISA Kit
Occurrence of infection	3 months	any symptoms of infection Include (Redness, Edema and pain at the site of infection)
Treatment-related side effects.	3 months	by asking the patient by phone call

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026